MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) ATLAS PTA BALLOON DILATATION CATHETER

Model Number AT75144

Device Problems Material Frayed (1262); Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.This is the only complaint reported to date for this lot number and failure mode.The device was returned for evaluation.A visual inspection found frayed fibers in the balloon barrel and distal cone.Fiber disturbance and slight peeling of the outer pebax layer were also found in the balloon barrel.Therefore, the investigation is confirmed for frayed fibers and peeled pebax.Per the reported event details, the device was inflated inside a stent during the procedure.Therefore, it is possible that the interaction between the stent and the balloon contributed to the reported issues.However, the definitive root cause for the reported issues could not be determined based upon the available information.The device is labeled for single use.

Event Description

This report summarizes one (1) malfunction event.A review of the events indicated that model at75144 pta balloon dilatation catheter during pre-dilatation of a stent in the right brachiocephalic vein, allegedly experienced frayed material and a peeled outer layer, upon removal from the patient.The procedure was completed with another device.This report was received from one source.This event involved one male patient, (b)(6) and approximately (b)(6).This patient had no reported patient injury.

• Brand Name: ATLAS PTA BALLOON DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8523916
• MDR Text Key: 142497397
• Report Number: 2020394-2019-00414
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741062438
• UDI-Public: (01)00801741062438
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AT75144
• Device Catalogue Number: AT75144
• Device Lot Number: GFCY1597
• Initial Date Manufacturer Received: 03/31/2019
• Initial Date FDA Received: 04/17/2019
• Type of Device Usage: N
• Patient Sequence Number: 1